Field Safety Notices: 2 to 6 August 2021 List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 August

Source: MHRA 9th August 2021


If you receive a field safety notice (FSN) from a manufacturer you must always act on it. MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs.

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website.

Abbott: Vysis CLL FISH Probe Kit

4 August 2021

IVD, genetic testing

MHRA reference: 2021/008/006/000/010

Abbott Laboratories: Alinity ci-series System Control Module (SCM)

26 July 2021

IVDs, clinical chemistry

MHRA reference: 2021/007/029/291/005

Armstrong Medical: 2105489-003 AMSORB PLUS PREFILLED G-CAN 1.0L

3 August 2021

Gas absorbers

Model: AMAB3801 and AMAB3801GE

MHRA reference: 2021/007/026/487/007

Beckman Coulter: Remisol Advance

22 July 2021

IVDs, haematology

Model: DiffPad

MHRA reference: 2021/007/027/601/001

Becton Dickinson: B9SmartSite Needle Free Valve

3 August 2021

Infusion & transfusion, connectors

MHRA reference: 2021/006/029/291/013

Boston Scientific: TheraSphere Administration Sets

29 July 2021

Infusion & transfusion, administration sets

MHRA reference: 2021/007/030/487/001

Coloplast: Supraflow supra-pubic drainage set

27 July 2021

Urinary catheters and accessories

MHRA reference: 2021/007/027/291/008

Elekta: Monaco RTP System

August 2021

Radiotherapy planning and verification systems

MHRA reference: 2021/008/006/000/009

GAMA Healthcare: Clinell Universal Wipes

26 July 2021

Disinfectants for medical devices

Model: CW200

MHRA reference: 2021/005/005/601/530

Olympus Medical Systems: Forceps/Irrigation Plug (Isolated Type)

2 August 2021

Endoscopes, flexible

Model: MAJ-891

MHRA reference: 2021/007/029/291/023

PROCEPT BioRobotics Corporation: AquaBeam Handpiece

9 July 2021

Therapy tissue ablation

Model: HP2000

MHRA reference: 2021/007/023/701/058

Randox Laboratories: Calibration Serum Level 3

29 March 2021

IVDs, clinical chemistry

Model: CAL2351

MHRA reference: 2021/007/027/601/500

Roche Diagnostics: Accu-Chek Aviva, Performa and Inform II test strip

22 July 2021

IVDs, self / home testing

MHRA reference: 2021/007/021/291/002

Roche Diagnostics: cobas SARS-CoV-2 & Influenza A/B


IVDs, SARS-CoV-2 PCR test

MHRA reference: 2021/007/030/487/003

SureScreen Diagnostics: Antigen Rapid Test

29 July 2021

IVDs, SARS-CoV-2 lateral flow antigen test


MHRA reference: 2021/007/029/601/005

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